The user facility reported a 64-year-old female undergoing cardiac surgery was implanted with an impella device for mechanical circulatory support.While on support, the impella catheter kinked.Multiple attempts to manipulate the catheter failed, and the device was removed.
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The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.This report is being filed as part of a retrospective review of historical records.
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